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. 2015 Jun 27;43(1):115–127. doi: 10.1002/jmri.24971

Utilization and likelihood of radiologic diagnostic imaging in patients with implantable cardiac defibrillators

Saman Nazarian 1,, Matthew R Reynolds 2, Michael P Ryan 3, Steven D Wolff 4, Sarah A Mollenkopf 5, Mintu P Turakhia 6
PMCID: PMC4755166  PMID: 26118943

Abstract

Purpose

To examine imaging utilization in a matched cohort of patients with and without implantable cardioverter defibrillators (ICD) and to project magnetic resonance imaging (MRI) utilization over a 10‐year period.

Materials and Methods

The Truven Health MarketScan Commercial claims and Medicare Supplemental health insurance claims data were used to identify patients with continuous health plan enrollment in 2009–2012. Patients with ICDs were identified using ICD‐9 and CPT codes, and matched to patients with the same demographic and comorbidity profile, but no record of device implantation. Diagnostic imaging utilization was compared across the matched cohorts, in total, by imaging categories, and in subpopulations of stroke, back pain, and joint pain. MRI use in the nonimplant group over the 4‐year period was extrapolated out to 10 years for ICD‐indicated patients.

Results

A cohort of 18,770 matched patients were identified; average age 65.5 ± 13.38 and 21.9% female. ICD patients had significantly less MRI imaging (0.23 0.70 SD vs. 0.00 0.08 SD, P < 0.0001) than nonimplant patients. Among patients with records of stroke/transient ischemic attack (TIA) (ICD 5%, nonimplant 4%) and accompanying diagnostic imaging, 44% of nonimplant patients underwent MRI vs. 1% of ICD patients (P < 0.0001). Forecast models estimated that 53% to 64% of ICD‐eligible patients may require an MRI within 10 years.

Conclusion

MRI utilization is lower in ICD patients compared to nonimplant patients, yet the burden of incident stroke/TIA, back, and joint pain suggests an unmet need for MR‐conditional devices. J. MAGN. RESON. IMAGING 2016;43:115–127.

Keywords: defibrillation, heart‐assist device, magnetic resonance imaging, implantable cardioverter defibrillators, healthcare utilization


Over the past decade the use of magnetic resonance imaging (MRI) has witnessed a sharp increase1, 2, 3 as the modality of choice for diagnosing a spectrum of conditions.4 For joint pain and lower back pain, MRI is cited as an appropriate diagnostic method by the American College of Radiology.5 For stroke, an MRI method known as diffusion‐weighted imaging (DWI), has emerged as a sensitive and specific technique.6, 7, 8 In these conditions and others, such as cardiomyopathy,9, 10, 11, 12 MRI has emerged as a preferred imaging modality because it provides excellent spatial resolution without exposing patients to ionizing radiation, iodinated contrast agents, and risks of invasive procedures.13

The use of MRI technology is expected to grow in tandem with the expanding number of cardiovascular patients,13 and the increasing number of cardiovascular indications for MRI.5, 11 At the same time, there is a corresponding rise in the volume of patients receiving implantable cardioverter defibrillators (ICDs),13, 14 with an estimated 2.9 million implanted between 1993–2009 in the U.S..15 In 2013, the National ICD Registry published a report on the latest entries into its database, including the number of ICDs implanted in the U.S. for quarters 2–4 in 2010 and all of 2011. According to the report, there were ∼263,000 ICD procedures over the time period, translating to 12,500 per month.16

The importance of MRI in the growing population of ICD recipients is underscored by the ongoing concerns regarding its safety. MRI scanners utilize static and gradient magnetic fields and radiofrequency energy11, 12 that can disable or reset ICD electronics, result in inappropriate therapies or inhibit needed therapy, exert force upon the generator, or heat ICD components.14 The U.S. Food and Drug Administration (FDA), in a statement updated in 2014, advises caution and summarizes possible hazards of ICD interaction with MRI.17 Also in 2014, the Canadian Heart Rhythm Society and Canadian Association of Radiologists published a Consensus Statement summarizing potential risks in scanning patients with non‐MR conditional devices. The Statement notes that scanning of these patients is not endorsed by Health Canada, and should be avoided unless there is a compelling medical need.18

Studies have shown that MRI examination can safely be performed on modern ICD recipients if safety protocols are followed.19, 20 Yet, despite the growing evidence, the safety concerns continue, and the impact of ICD implantation on diagnostic imaging utilization has not been clearly defined.

The purpose of this study was to examine imaging utilization in a matched cohort of patients with and without ICDs and to project MRI utilization over a 10‐year period.

Materials and Methods

The methodology compares utilization of imaging in the ICD and nonimplant cohorts to illustrate the gap in volume of imaging linked to restrictions in its use in patients with ICDs. The study also compares utilization in subsets of the cohorts, including stroke, back pain, and joint pain. Four calendar years of MRI utilization in the nonimplant cohort was utilized to forecast the potential utilization for MRI over a 10‐year time horizon.

Data Source

This study used data from the Truven Health MarketScan Commercial Claims and Medicare Supplemental Research Databases, which contain Health Insurance Portability and Accountability Act (HIPAA)‐compliant, individual‐level, deidentified, healthcare claims information from employers, health plans, hospitals, Medicare, and Medicaid programs. Research using MarketScan data has been widely published in peer‐reviewed journals, including the field of imaging.21, 22 A protocol describing the study objectives, criteria for patient selection, data elements of interest, and statistical methods was submitted to the New England Institutional Review Board (NEIRB) and deemed exempt from review (NEIRB #13–343).

Patient Selection and Identification

Patient‐level data were extracted from the Truven Health MarketScan Research Databases for the years 2009–2012. Two cohorts were defined: 1) patients having a record of an ICD implant: "ICD implant cohort"; 2) patients without a record of a cardiac device or other implantable device that is contraindicated for MRI: "nonimplant cohort." The following inclusion/exclusion criteria were then applied to each cohort:

  1. ICD Implant Cohort: Patients with continuous health plan enrollment in the calendar year 2012 who had a record of an ICD implant for that entire calendar year were identified (Appendix Implant Code Combinations, implant codes). (Note: patients had to have a record of an implant prior to the start of the calendar year 2012 and could not have a record of an explant [Appendix Explant Codes] anytime during that year).

  2. Nonimplant Cohort: Patients with continuous health plan enrollment in 2009–2012 without a record of any cardiac or contraindicated MRI implant or related monitoring codes (Appendix Implant Code CombinationsInterrogation and Evaluation Codes) during the entire 4‐year time period were identified.

Variables of Interest

The main outcome measure analyzed was yearly (2012) diagnostic imaging utilization which was organized into the following six categories: 1) computed tomography (CT) and computed tomography angiography (CTA);2 MRI and magnetic resonance angiogram (MRA); 3) ultrasound, echo, Doppler, and duplex; 4) X‐ray and fluoroscopy; 5) nuclear; and 6) other. Diagnostic imaging utilization was then measured two different ways: i) by the number of procedures overall and across each category, and ii) by the number of actual patients having a procedure within each category.

The main independent variable for this analysis was whether a patient was in the ICD cohort or the nonimplant cohort. Explanatory variables included patient demographics (age, gender, and type of plan) and patient comorbidities (diabetes, hypertension, chronic pulmonary obstruction disease [COPD], etc.). See Appendix Comorbid Condition Codes and Anticoagulation Specification for a complete listing of all comorbidities and their corresponding diagnostic codes.

Three additional variables were created to further subdivide the population. This included patients with a diagnosis code on record for the year 2012 for the following diseases: acute stroke, back pain, and joint pain. For the calendar year 2012, patients with ICD‐9 diagnosis codes for stroke or transient ischemic attack (TIA) had their diagnostic imaging utilization summarized within ±3 days of the stroke/TIA event. Patients with ICD‐9 diagnosis codes for back pain or joint pain had their diagnostic imagining utilization summarized within 3 days before and 30 days after their first diagnosis on record.

Statistical Analysis

All data were imported and maintained in SAS data files. Tabulation of summary statistics, graphical presentations, and data analyses were performed using SAS v. 9.2. (SAS Institute, Cary, NC).

Once all variables were created, patients in the ICD implant cohort were matched 1:1 using a combination of direct (age, gender, type of plan) and propensity score matching (comorbid conditions) to patients in the nonimplant cohort. A full list of comorbid conditions used for the propensity score are listed in Appendix Comorbid Condition Codes and Anticoagulation Specification. Propensity score matching, or conditional probability of assignment to a particular treatment given a set of observed characteristics, has been shown to balance the number of confounders among matched cohorts. The propensity score was calculated from a logistic regression model as the probability that a patient was assigned to a particular treatment given the patient's comorbid conditions. From this model, individual propensity scores were calculated for each patient as a measure of the likelihood that the patient would have been in the ICD cohort versus the nonimplant cohort. An SAS macro from the Mayo Clinic (gmatch) was used to create a greedy match based on the propensity score.23, 24 This method utilizes random selection of treatment subjects and chooses the nearest matching nonimplant subject. Once matched, the pairs will not be broken, even for a more optimal match.

Propensity Score Logit Model:

pi=e(β0+β1X1i++βpXpi)1+e(β0+β1X1i++βpXpi)

Where pi is the likelihood of ICD implant for the ith patient (i = 1,…,n) and X1i…Xip are covariate characteristics for the ith patient.

Diagnostic imaging utilization was compared across the matched cohorts, in total, by imaging category (MRI, CT scan, X‐ray, etc.), and for MRI by body area for the calendar year 2012. The same comparison was carried out for the following three subpopulations of interest: acute stroke/TIA, back pain, and joint pain.

Predicting the Probability of MRI Utilization: 10‐Year Time Horizon

In an effort to further understand MRI utilization, the nonimplant matched cohort was used to measure the percent of patients with ICDs who needed an MRI over the 4‐year period.(2009 ‐2012) This survival data were then fitted with exponential functions to forecast a range of best fit scenarios, as measured by the coefficient of determination, out to 10 years.

Results

A total of 97,150,333 patients from the Truven Health MarketScan Research Databases were identified as meeting the initial inclusion criteria. For the 1) ICD Implant Cohort, a total of 12,615 patients had continuous health plan enrollment in the calendar year 2012 and a record of an ICD implant for that entire calendar year. For the 2) Nonimplant Cohort, a total of 13,112,933 patients had continuous health plan enrollment in 2009–2012 without a record of any cardiac or contraindicated MRI implant or related monitoring codes during the entire 4‐year time period. After 1:1 matching, the final sample was a total of 18,770 with 9,385 patients in each cohort. See Fig. 1 for the complete attrition diagram.

Figure 1.

Figure 1

Patient attrition diagram. ICD: implantable cardioverter defibrillator.

Patient demographics and comorbid conditions in the matched cohorts are shown in Tables 1 and 2. Since direct matching was used for age, gender, and type of plan, distributions were virtually equal across cohorts. Over 70% in each cohort were 60 years of age or older and ∼78% male. Medicare and commercial insurance were distributed fairly equally, with ∼53% being Medicare and 47% commercial. The highest concentration of patients by region occurred in the north central (30%) and south (34%). All standardized differences for demographics and comorbid conditions were <0.01, except for region.

Table 1.

Patient Demographics After Matching

Total Cohort
ICD Nonimplant Standardized difference
N % N % N %
Total N 18,770 100.0 9,385 100.0 9,385 100.0
Age in January 2012
<18 128 0.7 65 0.7 63 0.7 0.0066
18–29 188 1.0 94 1.0 94 1.0
30–39 323 1.7 165 1.8 158 1.7
40–49 1,247 6.6 636 6.8 611 6.5
50–59 3,667 19.5 1,866 19.9 1,801 19.2
60–69 5,512 29.4 2,750 29.3 2,762 29.4
70–79 4,787 25.5 2,362 25.2 2,425 25.8
80+ 2,918 15.6 1,447 15.4 1,471 15.7
Gender
Male 14,654 78.1 7,327 78.1 7,327 78.1 0.0000
Female 4,116 21.9 2,058 21.9 2,058 21.9
Commercial or Medicare in January 2012
Commercial 8,797 46.9 4,365 46.5 4,432 47.2 0.0143
Medicare 9,973 53.1 5,020 53.5 4,953 52.8
Insurance plan in January 2012
Missing/unknown 538 2.9 381 4.1 157 1.7 0.0836
Comprehensive 5,574 29.7 2,787 29.7 2,787 29.7
EPO 196 1.0 108 1.2 88 0.9
HMO 2,185 11.6 966 10.3 1,219 13.0
POS 1,084 5.8 522 5.6 562 6.0
PPO 8,568 45.7 4,301 45.8 4,267 45.5
POS with Capitation 24 0.1 12 0.1 12 0.1
CDHP 437 2.3 218 2.3 219 2.3
HDHP 164 0.9 90 1.0 74 0.8
Region in January 2012
Northeast region 3,271 17.4 1,636 17.4 1,635 17.4 0.1849
North central region 5,647 30.1 2,883 30.7 2,764 29.5
South region 6,507 34.7 3,330 35.5 3,177 33.9
West region 3,176 16.9 1,386 14.8 1,790 19.1
Unknown region 169 0.9 150 1.6 19 0.2

CDHP: Consumer Driven Health Plans; EPO: Exclusive Provider Organization; HDHP: High Deductible Health Plan; HMO: Health Maintenance Organization; ICD: implantable cardioverter defibrillator; POS: Point Of Service; PPO: Preferred Provider Organization.

Table 2.

Comorbid Conditions After Matching

Total Cohort
ICD Nonimplant Standardized difference
N % N % N %
All patients 18,770 100.0 9,385 100.0 9,385 100.0
Rheumatoid arthritis 262 1.4 136 1.5 126 1.3 0.0091
Psoriatic arthritis 41 0.2 22 0.2 19 0.2 0.0068
Ankylosing spondylitis 15 0.1 5 0.1 10 0.1 0.0189
Skin cancer 964 5.1 529 5.6 435 4.6 0.0454
Colon cancer 105 0.6 63 0.7 42 0.5 0.0300
Lung, bronchus, or trachea 150 0.8 82 0.9 68 0.7 0.0168
GERD 1,623 8.7 814 8.7 809 8.6 0.0019
Gastritis 618 3.3 312 3.3 306 3.3 0.0036
Gastric ulcer 81 0.4 51 0.5 30 0.3 0.0341
Crohn's disease 79 0.4 37 0.4 42 0.5 0.0082
Ulcerative colitis 68 0.4 37 0.4 31 0.3 0.0106
Diverticulitis 158 0.8 79 0.8 79 0.8 0.0000
Kidney stones 451 2.4 240 2.6 211 2.3 0.0202
Cystitis 229 1.2 126 1.3 103 1.1 0.0223
Depressive disorders 1,581 8.4 750 8.0 831 8.9 0.0311
Neurotic disorders 1,124 6.0 500 5.3 624 6.7 0.0557
Heart failure 7,986 42.6 4,109 43.8 3,877 41.3 0.0500
MI (any) 2,570 13.7 1,347 14.4 1,223 13.0 0.0384
Angina 1,286 6.9 654 7.0 632 6.7 0.0093
Other coronary artery Disease 11,545 61.5 5,794 61.7 5,751 61.3 0.0094
Stroke 547 2.9 309 3.3 238 2.5 0.0450
TIA 430 2.3 226 2.4 204 2.2 0.0157
Cardiac dysrhythmias 11,687 62.3 5,793 61.7 5,894 62.8 0.0222
Sleep apnea 2,417 12.9 1,152 12.3 1,265 13.5 0.0360
Hypertension 12,373 65.9 6,208 66.2 6,165 65.7 0.0097
Irritable bowel disease 152 0.8 58 0.6 94 1.0 0.0428
Lumbar disk disease 969 5.2 465 5.0 504 5.4 0.0188
Osteoporosis 371 2.0 192 2.1 179 1.9 0.0100
Osteoarthritis 3,206 17.1 1,639 17.5 1,567 16.7 0.0204
Parkinson's disease 137 0.7 79 0.8 58 0.6 0.0263
Multiple sclerosis 51 0.3 19 0.2 32 0.3 0.0266
Migraine 181 1.0 69 0.7 112 1.2 0.0469
Obstructive chronic bronchitis 784 4.2 457 4.9 327 3.5 0.0693
Emphysema 355 1.9 199 2.1 156 1.7 0.0336
Chronic obstructive asthma 201 1.1 114 1.2 87 0.9 0.0280
Bronchiectasis 64 0.3 42 0.5 22 0.2 0.0366
Extrinsic allergic alveolitis 6 0.0 4 0.0 2 0.0 0.0119
Chronic airway obstruction NEC 2,268 12.1 1,262 13.5 1,006 10.7 0.0838
Eczema (dermatitis) 580 3.1 291 3.1 289 3.1 0.0012
Sebaceous gland diseases 546 2.9 284 3.0 262 2.8 0.0139
Diabetes 6,410 34.2 3,245 34.6 3,165 33.7 0.0180
Hyperlipidemia 10,667 56.8 5,276 56.2 5,391 57.4 0.0247
Hypothyroidism 2,079 11.1 991 10.6 1,088 11.6 0.0329
Anticoagulants usage 4,170 22.2 2,126 22.7 2,044 21.8 0.0210
Atrial fibrillation 5,996 31.9 2,760 29.4 3,236 34.5 −0.1089
Hypertrophic cardiomypathy 382 2.0 357 3.8 25 0.3 0.2525
Sarcoidosis 87 0.5 72 0.8 15 0.2 0.0895

GERD: gastroesophageal reflux disease; MI: myocardial infarction; NEC: not elsewhere classified; TIA: transient ischemic attack.

After matching, ICD patients had significantly less imaging per patient compared to the nonimplant cohort (4.3 6.10 SD vs. 5.6 7.87 SD, P < 0.0001). ICD patients had significantly less MRI (0.23 0.70 SD vs. 0.00 0.08 SD, P < 0.0001) than the nonimplant cohort.

When evaluating the breakdown of procedures by imaging modality, there was a lower utilization of all imaging among ICD patients, with the most marked differences in MRI/MRA (2,121 nonimplant vs. 37 ICD), X‐ray and fluoroscopy (25,956 nonimplant vs. 19,577 ICD), and ultrasound (16,543 nonimplant vs. 13,692 ICD) (Fig. 2A). These differences were similar in the patient‐level analysis (Fig. 2B). Among those patients of each 9385 cohort, who had an MRI, the most frequently occurring MRI was of the brain (29% nonimplant vs. 30% ICD). Table 3 shows the number and percent of MRIs for each cohort by body area.

Figure 2.

Figure 2

A: Total number of procedures for each cohort by radiology category. B: Number of patients for each cohort by radiology category. ICD: implantable cardioverter defibrillator; CT: computed tomography; CTA: computed tomography angiography; MRI: magnetic resonance imaging; MRA: magnetic resonance angiogram.

Table 3.

MRI/MRA Scans by Body Area

Location ICD Nonimplant
Total 37 2123a
N % N %
Abdomen 2 5% 112 5%
Brain 11 30% 607 29%
Cardiac, breast, & chest 1 3% 91 4%
Head 0 0% 132 6%
Lower extremities 6 16% 274 13%
Neck 0 0% 87 4%
Other 0 0% 37 2%
Pelvis 0 0% 58 3%
Spine ‐ chest 2 5% 77 4%
Spine ‐ lumbar 9 24% 326 15%
Spine ‐ neck 2 5% 187 9%
Upper extremities 4 11% 135 6%
a

Includes two instances of the same subcategory of MRI on the same day, causing that MRI to only be counted once previously.

MRA: magnetic resonance angiogram; MRI: magnetic resonance imaging.

Table 4 depicts the overall differences in imaging utilization between ICD and nonimplant patients across the three subpopulations: stroke/TIA, back pain, and joint pain. Among patients with records of stroke/TIA (ICD 5%, nonimplant 4%) and accompanying diagnostic imaging, 44% of nonimplant patients underwent MRI vs. 1% of ICD patients (P < 0.0001) (Fig. 3A) and nonimplant patients had more imaging tests overall (4.1 2.47 SD vs. 3.2 2.16 SD, P < 0.0001). Among patients with records of back pain and accompanying diagnostic imaging, 22% of nonimplant patients underwent MRI vs. 0.7% of ICD patients (P < 0.0001) (Fig. 3B), and nonimplant patients had more imaging tests overall (2.5 2.80 SD vs. 2.0 2.04 SD, P = 0.0003). By comparison, patients with records of back pain and ICDs underwent a statistically significantly larger volume of CT and CTA (32%) as compared to the nonimplant cohort (21%) (P = 0.0011). Among patients with records of joint pain and accompanying diagnostic imaging, 17% of nonimplant patients underwent MRI vs. 0.1% of ICD patients (P < 0.0001) (Fig. 3C), and nonimplant patients had more imaging tests overall (2.5 2.77 SD vs. 2.1 1.89 SD, P < 0.0001). Similar to the back pain subgroup, patients with joint pain records and ICDs underwent CT and CTA more often (19%) than patients with joint pain in the nonimplant cohort (16%). The difference, however, was not statistically significant.

Table 4.

Subgroup Radiology

Subpopulation Category ICD Nonimplant
Number of patients Number of procedures Number of patients Number of procedures P‐value
Stroke/TIA Total patients (% of total) 442 (5%) 379 (4%)
Total with imaging 304 962 285 1,160
CT & CTA 228 339 204 294 0.8916
MRI & MRA 3 3 125 184 <.0001
Nuclear 11 11 5 5 0.2274
Other 0 0 1 1 0.2804
Ultrasound/Echo/Doppler/Duplex 209 334 206 349 0.0165
X‐Ray & Fluoroscopy 184 275 194 327 0.0003
Back pain Total patients (% of total) 1,552 (17%) 1,681 (18%)
Total with imaging 869 1,776 930 2,284
CT & CTA 274 349 198 262 0.0011
MRI & MRA 6 6 203 235 <.0001
Nuclear 49 51 72 76 0.0850
Other 0 0 1 1 0.3175
Ultrasound/echo/Doppler/duplex 235 324 270 422 0.0626
X‐ray & fluoroscopy 694 1,046 744 1,288 0.0501
Joint pain Total patients (% of total) 2,073 (22%) 2,355 (25%)
Total with imaging 1,456 3,005 1,668 4,142
CT & CTA 273 347 270 347 0.1649
MRI & MRA 2 2 277 315 <.0001
Nuclear 102 105 109 117 0.8886
Other 1 1 2 2 0.6339
Ultrasound/echo/Doppler/duplex 403 568 500 764 0.0193
X‐ray & fluoroscopy 1,280 1,982 1,472 2,597 0.0009

CT: computed tomography; CTA: computed tomography angiography; MRI: magnetic resonance imaging; MRA: magnetic resonance angiogram.

Figure 3.

Figure 3

A: Percentage of patients with stroke/TIA event by radiology type. B: Percentage of patients with back pain by radiology type. C: Percentage of patients with joint pain by radiology type. ICD: implantable cardioverter defibrillator; CT: computed tomography; CTA: computed tomography angiography; MRI: magnetic resonance imaging; MRA: magnetic resonance angiogram.

The proportion of nonimplant patients who received an MRI or MRA at 1, 2, 3, and 4 years and projected to 10 years are shown in Fig. 4. These ICD‐indicated patients had a projected MRI or MRA utilization of between 53% and 64% within 10 years.

Figure 4.

Figure 4

MRI/MRA use by ICD‐indicated patients and projected utilization to 10 years. The black line represents the proportion of ICD‐indicated patients who received an MRI or MRA at 1, 2, 3, and 4 years. The lines extending after year 4 show two projections, which are high and low estimates of utilization. MRI: magnetic resonance imaging; MRA: magnetic resonance angiogram; ICD: implantable cardioverter defibrillator.

Discussion

These findings of minimal utilization of MRIs among ICD patients suggest continued reluctance to perform MRIs in those patients and an unmet need for MRIs, yet this practice conflicts with the current trend toward greater use of complex imaging. The volume of patients with ICDs is growing, and for much of the last decade Medicare Part B spending on complex scanning methods, including MRI, rose an average 17% per year. This indicates a spending pattern that is nearly twice that of spending on ultrasound, radiography, and other standard imaging procedures.2 MRI volume flattened somewhat mid‐decade,25 following implementation of the Deficit Reduction Act in 2007,26 but the overall trajectory is upward.1 According to a recent report from the Medicare Payment Advisory Committee, the number of brain MRIs per 1000 Medicare beneficiaries rose to 75 in 2012, up from 44 in 2000. Likewise, the number of "other" MRIs jumped to 129 per 1000 in 2012, versus 58 in 2000.

Further evidence of the growing role of MRIs comes from Appropriateness Criteria from the American College of Radiology, which are evidenced‐based guidelines designed to help imaging decision‐making. The Appropriateness Criteria consistently rank MRI as an appropriate diagnostic tool for a wide range of musculoskeletal, neurologic, cardiac, and other conditions.5 In the case of low back pain, for example, MRI is highly rated as a preferred modality, ranking an "8" out of a possible "9" for patients with a suspicion of cancer, infection, or immunosuppression, or in patients with low‐velocity trauma, osteoporosis, focal and/or progressive deficit, prolonged symptom duration, or greater than 70 years of age. By comparison, for this same indication, use of a CT scan is rated "6," which suggests this approach "may be appropriate." Similarly, for pain in the hip joint, an MRI without contrast is rated a "9" for patients who are radiograph negative, equivocal, or nondiagnostic, and have suspected osseous or surrounding soft‐tissue abnormality, excluding osteoid osteoma. A CT scan for this indication is rated "2," which translates as "usually not appropriate."

Given the evidenced‐based importance of MRI as a valued diagnostic tool, its minimal use in ICD patients is a concern. Our study revealed this same pattern of sharply different MRI/MRA utilization among the three matched subpopulations of interest: acute stroke/TIA, back pain, and joint pain.

At the time of this analysis, MR‐conditional ICDs were not available in the U.S., but our finding of an unmet need for imaging in patients with ICDs is similar to results from a European study where conditional ICDs have been available for a few years. A study of 51 European Heart Rhythm Association centers by Marinskis et al27 focused on MRIs in patients with ICDs, and 65.8% reported never performing MRI on non‐MR‐conditional ICD recipients.

Our results indicate that despite the growing literature regarding the safety of MRI in the setting of implanted legacy ICDs,19 widespread adaptation of safety protocols has not occurred. In the course of evaluating a protocol for safely imaging ICD patients, a prospective study conducted 555 MRIs in 438 patients. They found devices of three patients reverted to back‐up programming mode and decreases in right ventricular (RV) sensing, as well as atrial, right and left ventricular lead impedances. Interrogations at 6 months showed decreased RV sensing, decreased RV lead impedance, increased RV capture threshold, and decreased battery voltage. It is important to note that none of the reported changes required device revision or reprogramming.19 The MagnaSafe Registry reported on 500 patients with an ICD who have had a nonthoracic MRI. They report that no deaths, generator or lead failures, loss of capture, or ventricular arrhythmias occurred and found that one or more clinically relevant device parameter changes occurred in 29% of ICD patients. The generator of one ICD was later replaced due to inappropriate activation of tachytherapy during the MRI.28 The hesitation to adopt such safety protocols is partially attributable to the current lack of an FDA‐approved MR‐conditional ICD and Medicare coverage restrictions regarding MRI scans in patients with ICDs. It is possible that with additional safety data the U.S. FDA and CMS will review and revise their MRI coverage policy; however, substantial safety data will understandably be needed.

An important outcome of our study is that more than half, 53%–64%, of ICD‐indicated patients are projected to require MRI within a decade, a result that is consistent with previous research.4 Kalin and Stanton4 reported that the combination of greater MRI use and more patients with ICDs coupled with expanded Medicare coverage leads to a projected range from 50% to 75% of ICD patients needing an MRI over the lifetime of the device.

This study adds to the literature, as it had sizeable cohorts to highlight the nominal use of MRIs in patients with ICDs, reflecting ongoing safety concerns.13 Moreover, this research indicates the need for MR‐conditionally safe ICDs and appropriate protocols that will increase the likelihood that MRIs can be performed safely in individuals implanted with these devices. Currently, there is a growing body of research on careful use of MRIs in patients implanted with ICDs.11, 19, 29 Van der Graaf et al29 describe the status of MRI and implantable electronic devices, including ICDs, and report on four ongoing clinical trials studying MR‐conditional pacing devices. The European Society of Cardiology (ESC) on cardiac pacing and cardiac resynchronization therapy (CRT) recently published guidelines that suggest that MRI can be safely performed in patients with ICDs if strict safety conditions are met.30 These guidelines represent a major shift in the previously accepted standard that patients with a pacemaker or ICD should not undergo MRI.29

There are several important limitations to consider. First, although data sources were large and contemporary, variables were based on medical claims designed for billing purposes, and unidentified confounders may be present, which could affect the precision of the prediction model. Second, we are unable to ascertain indication for imaging, which could help generate precise estimates of likelihood of need or MRI based on comorbidities, or clarify conditions or indications in which non‐MRI alternatives could be suitable. Third, findings may not be generalizable to other countries or non‐fee for service healthcare systems, which may have lower rates of imaging utilization. Finally, patient outcomes related to receiving MRI versus not could not be determined from this claims analysis.

In conclusion, MRI utilization is lower in ICD patients compared to nonimplant patients, and disparities are seen in access to MRI among the three subgroups of interest. One in 25 ICD patients would have qualified for imaging for a recorded stroke/TIA, yet less than 1% received MRI for this indication. We project that ∼53%–64% of ICD patients are likely to need an MRI over a 10‐year time horizon, highlighting the importance of MR‐conditional ICDs for this patient population.

Acknowledgments

Contract grant sponsor: Medtronic.

Implant Code Combinations

CPT Code Explant Type
# 00.50 CRT‐P
# 00.50, 33208, 33225 CRT‐P
# 00.50, 33225 CRT‐P
# 00.50, 33207, 33225 CRT‐P
# 37.72, 37.83, 33208, 33225 CRT‐P
# 00.50, 33208 CRT‐P
# 33208, 33225 CRT‐P
# 00.50, 33207, 33208, 33225 CRT‐P
# 33207, 33225 CRT‐P
# 37.72, 37.83, 33225 CRT‐P
# 37.83, 33208, 33225 CRT‐P
# 37.72, 37.83 Pacemaker
# 37.72, 37.83, 33208 Pacemaker
# 37.72, 37.80, 33208 Pacemaker
# 37.80,37.83, 33208 Pacemaker
# 33208 Pacemaker
# 37.72, 33208 Pacemaker
# 37.72, 37.83, 33207, 33208 Pacemaker
Code Combination Implant Type
# 37.70, 37.83, 33208 Pacemaker
# 37.72, 37.80, 37.83 Pacemaker
# 37.72, 37.80, 37.83, 33208 Pacemaker
# 37.72, 37.83, 33207, 33225 Pacemaker
# 37.73, 37.80 Pacemaker
# 37.73, 37.82, 33206, 33207 Pacemaker
# 37.73, 37.82, 33208 Pacemaker
# 37.80, 33206 Pacemaker
# 37.80, 33207 Pacemaker
# 37.82, 37.83, 33208 Pacemaker
# 37.83, 33207 Pacemaker
# 37.70, 37.82 Pacemaker
# 33206 Pacemaker
# 37.73, 37.81 Pacemaker
# 3781,33206 Pacemaker
# 37.73, 37.82 Pacemaker
# 37.73, 37.82, 33206 Pacemaker
# 37.73, 37.81, 33206 Pacemaker
# 37.71, 37.81 Pacemaker
# 37.71, 37.82 Pacemaker
Code Combination Implant Type
# 37.71, 37.82, 33207 Pacemaker
# 37.71, 37.81, 33207 Pacemaker
# 33207 Pacemaker
# 37.81, 37.82, 33207 Pacemaker
# 37.71, 37.81, 33207, 33208 Pacemaker
# 37.71, 37.80 Pacemaker
# 37.70, 37.81, 33207 Pacemaker
# 00.51 CRT‐D
# 00.51, 33225 CRT‐D
# 00.51, 33249 CRT‐D
# 00.51, 33249, 33225 CRT‐D
# 33249, 33225 CRT‐D
# 33249 ICD
# 37.94 ICD
# 37.94, 33249 ICD
# 37.94, 37.95 ICD
# 37.94, 37.95, 33249 ICD
# 37.94, 37.95, 37.96, 33249 ICD
# 37.94, 37.96, 33249 ICD
# 37.95, 33249 ICD
Code Combination Implant Type
# 37.95, 37.96 ICD
# 37.96, 33249 ICD
# 33282 Reveal

Explant Codes

CPT Code Explant Type
# 37.79 ICD or CRT‐D
# 37.89 PM
# 33227 PM
# 33233 PM
# 33234 PM
# 33235 PM
# 33236 PM
# 33237 PM
# 33238 ICD or PM
# 33241 ICD
# 33244 ICD
# 33284 ILR

Interrogation and Evaluation Codes

CPT Code Interrogation Code Description
# 93279 Pm Device Progr Eval Sngl
# 93280 Pm Device Progr Eval Dual
# 93281 Pm Device Progr Eval Multi
# 93282 Icd Device Prog Eval 1 Sngl
# 93283 Icd Device Progr Eval Dual
# 93284 Icd Device Progr Eval Mult
# 93285 Ilr Device Eval Progr
# 93288 Pm Device Eval In Person
# 93289 Icd Device Interrogate
# 93290 Icm Device Eval
# 93291 Ilr Device Interrogate
# 93293 Pm Phone R‐Strip Device Eval
# 93294 Pm Device Interrogate Remote
# 93295 Icd Device Interrogat Remote
# 93296 Pm/Icd Remote Tech Serv
# 93297 Icm Device Interrogat Remote
# 93298 Ilr Device Interrogat Remote
# 93299 Icm/Ilr Remote Tech Serv
CPT Code Interrogation Code Description
# 93287 ICD Evaluation Peri‐procedural
# 93741 ICD Evaluation (pre‐2009)
# 93742 ICD Evaluation (pre‐2009)
# 93743 ICD Evaluation (pre‐2009)
# 93744 ICD Evaluation (pre‐2009)
# 93286 PM Evaluation Peri‐procedural
# 93731 PM Remote Evaluation (pre‐2009)
# 93732 PM Remote Evaluation (pre‐2009)
# 93733 PM Remote Evaluation (pre‐2009)
# 93734 PM Remote Evaluation (pre‐2009)
# 93735 PM Remote Evaluation (pre‐2009)
# 93736 PM Remote Evaluation (pre‐2009)
# 93724 PM Electronic Analysis
# 93641 PM EP Evaluation
# 93642 PM EP Evaluation

Comorbid Condition Codes and Anticoagulation Specification

Condition ICD9 Code
Angina 411.1, 413.x
Ankylosing Spondylitis 720.0
Atrial Fibrillation 427.31
Back Pain 724.xx, 847.xx
Bronchiectasis 494.x
Cardiac Dysrhythmias 427.xx
Chronic Airway Obstruction NEC 496
Chronic Obstructive Asthma 493.2x
Colon Cancer 153.x
Crohn's Disease 555.xx
Cystitis 595.xx
Depressive Disorders 311, 300.4, 309.0, 309.1, 309.28, 298.0, 296.2x, 296.3x, 296.5x, 296.6x, 296.8x (except 296.81)
Diabetes 249.xx, 250.xx
Diverticulitis 562.11, 562.13
Eczema (Dermatitis) 692.9
Emphysema 492.x
Extrinsic Allergic Alveolitis 495.x
Gastric Ulcer 531.xx
Gastritis 535.xx (except 535.6x)
GERD 530.81
Heart Failure 398.91, 402.x1, 404.x1, 404.x3, 428.xx
Hyperlipidemia 272.0, 272.1, 272.2, 272.4, 272.9
Hypertension 401.x, 402.xx, 404.xx, 405.xx
Hypothyroidism 243, 244.x
Hypertrophic Cardiomypathy 425.11, 425.18
Irritable Bowel Disease 564.1
Joint Pain 716.xx, 718.xx 719.xx
Kidney Stones 592.x
Lumbar Disk Disease 722.10, 722.73, 722.52, 722.93
Lung, Bronchus, or Trachea 162.x
MI (any) 410.xx, 412, 411.0
Migraine 346.xx
Multiple Sclerosis 340
Neurotic Disorders 300.xx (without 300.4) + 309.81
Obstructive Chronic Bronchitis 491.2x
Osteoarthritis 721.x, 715.xx
Osteoporosis 733.0x
Other Coronary Artery Disease 411.81, 411.89, 414.0x, 414.2, 414.3, 414.4, 414.8, 414.9, 429.2, V45.81, V45.82
Parkinson's disease 332.x
Psoriatic Arthritis 696.0
Rheumatoid Arthritis 714.0
Sarcoidosis 135
Sebaceous Gland Diseases 706.x
Skin Cancer 176.0, 209.31–209.36, 172.x, 173.x
Sleep Apnea 327.2x, 780.51, 780.53, 780.57
Stroke 430, 431, 432.x, 433.x1, 434.x1, 997.02
TIA 435.x
Ulcerative Colitis 556.xx
Anticoagulation (included any of these) Anisindione, Antithrombin III Human, Antithrombin, Recombinant, Apixaban, Ardeparin Sodium, Argatroban, Bivalirudin, Citric Acid/Dextrose/Na Cit/Na Phos, Citric Acid/Dextrose/Sodium Citrate, Dabigatran Etexilate Mesylate, Dalteparin Sodium, Danaparoid Sodium, Desirudin, Dextrose/Heparin Sodium, Dicumarol, Enoxaparin Sodium, Fondaparinux Sodium, Heparin, Heparin Calcium, Heparin Sodium, Heparin/Dihydroergotamine, Lepirudin, Phenprocoumon, Rivaroxaban, Sodium Citrate, Tinzaparin Sodium, Warfarin Potassium, Warfarin Sodium

References

  • 1.Medpac: Medicare Payment Advisory Commission. A Data Book. Health Care Spending and the Medicare Program. June, 2014.
  • 2.United States Government Accountability Office. Medicare Part B Imaging Services. Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices. GAO‐08–452. June, 2008.
  • 3. Smith‐Bindman R, Miglioretti DL, Larson EB. Rising use of diagnostic medical imaging in a large integrated health system. Health Aff (Millwood) 2008;27:1491–1502. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 4. Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. Pacing Clin Electrophysiol 2005;28:326–328. [DOI] [PubMed] [Google Scholar]
  • 5.American College of Radiology. ACR Appropriateness Criteria®. http://www.acr.org/Quality‐Safety/Appropriateness‐Criteria.
  • 6. Jauch EC, Saver JL, Adams HP Jr, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2013;44:870–947. [DOI] [PubMed] [Google Scholar]
  • 7. Schellinger PD, Bryan RN, Caplan LR, et al. Evidence‐based guideline: the role of diffusion and perfusion MRI for the diagnosis of acute ischemic stroke: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2010;75:177–185. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 8. Wintermark M, Sanelli PC, Albers GW, et al. Imaging recommendations for acute stroke and transient ischemic attack patients: a joint statement by the American Society of Neuroradiology, the American College of Radiology, and the Society of NeuroInterventional Surgery. AJNR Am J Neuroradiol 2013;34:E117–127. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 9. Roguin A, Schwitter J, Vahlhaus C, et al. Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Europace 2008;10:336–346. [DOI] [PubMed] [Google Scholar]
  • 10. Marcu CB, Beek AM, van Rossum AC. Clinical applications of cardiovascular magnetic resonance imaging. CMAJ 2006;175:911–917. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 11. Gotte MJ, Russel IK, de Roest GJ, et al. Magnetic resonance imaging, pacemakers and implantable cardioverter‐defibrillators: current situation and clinical perspective. Neth Heart J 2010;18:31–37. [PMC free article] [PubMed] [Google Scholar]
  • 12. Nazarian S, Halperin HR. How to perform magnetic resonance imaging on patients with implantable cardiac arrhythmia devices. Heart Rhythm 2009;6:138–143. [DOI] [PubMed] [Google Scholar]
  • 13. Levine GN, Gomes AS, Arai AE, et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation 2007;116:2878–2891. [DOI] [PubMed] [Google Scholar]
  • 14. Nazarian S, Beinart R, Halperin HR. Magnetic resonance imaging and implantable devices. Circ Arrhythm Electrophysiol 2013;6:419–428. [DOI] [PubMed] [Google Scholar]
  • 15. Greenspon AJ, Patel JD, Lau E, et al. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures. J Am Coll Cardiol 2012;60:1540–1545. [DOI] [PubMed] [Google Scholar]
  • 16. Kremers MS, Hammill SC, Berul CI, et al. The National ICD Registry Report: version 2.1 including leads and pediatrics for years 2010 and 2011. Heart Rhythm 2013;10:e59–65. [DOI] [PubMed] [Google Scholar]
  • 17.U.S. Food and Drug Administration. A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107721.htm.
  • 18. Verma A, Ha AC, Dennie C, et al. Canadian heart rhythm society and canadian association of radiologists consensus statement on magnetic resonance imaging with cardiac implantable electronic devices. Can J Cardiol 2014;30:1131–1141. [DOI] [PubMed] [Google Scholar]
  • 19. Nazarian S, Hansford R, Roguin A, et al. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med 2011;155:415–424. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 20. Cohen JD, Costa HS, Russo RJ. Determining the risks of magnetic resonance imaging at 1.5 Tesla for patients with pacemakers and implantable cardioverter defibrillators. Am J Cardiol 2012;110:1631–1636. [DOI] [PubMed] [Google Scholar]
  • 21. Breslin TM, Banerjee M, Gust C, Birkmeyer NJ. Trends in advanced imaging use for women undergoing breast cancer surgery. Cancer 2013;119:1251–1256. [DOI] [PubMed] [Google Scholar]
  • 22. Lee DW, Foster DA. The association between hospital outcomes and diagnostic imaging: early findings. J Am Coll Radiol 2009;6:780–785. [DOI] [PubMed] [Google Scholar]
  • 23.Mayo Clinic. Gmatch macro developed by Erik Bergstralh and Jon Kosanke. 2003 http://www.mayo.edu/research/departments‐divisions/department‐health‐sciences‐research/division‐biomedical‐statistics‐informatics/software/locally‐written‐sas‐macros.
  • 24.Parsons LS. Reducing Bias in a Propensity Score Matched‐Pair Sample Using Greedy Matching Techniques. Paper presented at the Proceedings of the 26th Annual SAS Users Group International Conference. 2001. http://www2.sas.com/proceedings/sugi26/p214‐26.pdf.
  • 25. Lang K, Huang H, Lee DW, Federico V, Menzin J. National trends in advanced outpatient diagnostic imaging utilization: an analysis of the medical expenditure panel survey, 2000–2009. BMC Med Imaging 2013;13:40. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 26. Levin DC, Rao VM, Parker L. Trends in the utilization of outpatient advanced imaging after the deficit reduction act. J Am Coll Radiol 2012;9:27–32. [DOI] [PubMed] [Google Scholar]
  • 27. Marinskis G, Bongiorni MG, Dagres N, Dobreanu D, Lewalter T, Blomstrom‐Lundqvist C. Performing magnetic resonance imaging in patients with implantable pacemakers and defibrillators: results of a European Heart Rhythm Association survey. Europace 2012;14:1807–1809. [DOI] [PubMed] [Google Scholar]
  • 28. Russo RJ. Determining the Risks of Magnetic Resonance Imaging at 1.5 Tesla for Patients with Non‐MRI Conditional Pacemakers and Implantable Cardioverter Defibrillators: Final Results of The MagnaSafe Registry. Presentation at American Heart Association Scientific Sessions 2014: November 18, 2014 Chicago, IL.
  • 29. van der Graaf AW, Bhagirath P, Gotte MJ. MRI and cardiac implantable electronic devices; current status and required safety conditions. Neth Heart J 2014;22:269–276. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 30. Brignole M, Auricchio A, Baron‐Esquivias G, et al. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Europace 2013;15:1070–1118. [DOI] [PubMed] [Google Scholar]

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